An Interactive Internet Intervention for Adults With Insomnia (SHUTi)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by University of Virginia
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT01438697
First received: September 20, 2011
Last updated: December 13, 2011
Last verified: December 2011
  Purpose

This study will compare the efficacy of an interactive Internet intervention for adult insomnia (Sleep Healthy Using the Internet; SHUTi) to that of a static educational website to improve sleep, mood related symptoms, perceived health status, and overall quality of life.


Condition Intervention Phase
Insomnia
Sleep Initiation and Maintenance Disorders
Behavioral: Internet Intervention
Behavioral: Patient Education Website
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: An Internet Intervention for Insomnia: Efficacy and Dissemination

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Primary sleep symptoms: sleep onset latency (SOL), wake after sleep onset (WASO), insomnia severity (ISI) [ Time Frame: Baseline, 9 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary sleep symptoms: sleep efficiency (SE), number of night time awakenings, sleep quality, total sleep time (TST) [ Time Frame: Baseline, 9 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Psychological distress: levels of depression, levels of anxiety, sleep-related cognitions [ Time Frame: Baseline, 9 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Health symptoms: fatigue, quality of life [ Time Frame: Baseline, 9 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Cost effectiveness: program delivery cost, participant resource utilization and costs, quality adjusted life years (QALYs) [ Time Frame: 9 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Intervention Evaluation: perceived utility, perceived impact, intervention adherence, intervention use [ Time Frame: 9 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Exploratory Outcome Measures: health care access, coverage and utilization [ Time Frame: Baseline, 9 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internet Intervention Behavioral: Internet Intervention
Participants will spend 1-2 hours each week for 9 weeks using the Internet intervention. Users will complete daily sleep diaries as well as interactive tutorials covering the topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progress through the program they will receive tailored instructions for how to improve their sleep.
Other Name: Sleep Healthy Using the Internet (SHUTi)
Active Comparator: Patient Education Website Behavioral: Patient Education Website
Participants will be given access to a relevant patient education website. It will contain material addressing the behaviors and symptoms of insomnia.

Detailed Description:

Insomnia is defined by complaints of poor sleep, as well as difficulties initiating and/or maintaining sleep more than 3 nights/week for more than 6 months. Insomnia may contribute to daytime fatigue, impaired performance, confused thinking and judgment, and difficulty with work and personal tasks. Cognitive behavioral therapy (CBT) has been found to have significant short- and long-term benefits for people with insomnia. Access to CBT for many people, however, is limited, due to the high cost of treatment and a limited number of trained professionals. Delivering CBT for insomnia via the Internet could help make it more widely available. This study will compare the effectiveness of an online CBT intervention in improving sleep, mood, and quality of life in people with insomnia to that of a static educational website.

Participants in this study will be randomly assigned to receive the online CBT intervention or the static patient education website. The intervention period will last for 9 weeks. During the intervention period, participants assigned to the patient education website will be given content addressing strategies for dealing with insomnia. Those assigned to use the Internet intervention will review interactive, tailored content specific to the user's difficulties. Participants will complete questionnaires and two weeks of daily sleep diaries about their symptoms at four time points - at the beginning of the study, immediately after completing the 9 week program, 6 months later, and 12 months later.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 21 and 65 years old.
  • Have sleep-onset insomnia and/or sleep maintenance insomnia (>30 minutes for at least 3 nights/week).
  • Have insomnia symptoms lasting at least 6 months.
  • Have an average total sleep time ≤ 6.5 hours.
  • Sleep disturbances (or associated daytime fatigue) cause significant distress or impairment in social, occupational, or other areas of functioning.
  • Have regular access to a computer and the Internet.
  • Reside in the United States or are US Citizens living outside the United States

Exclusion Criteria:

  • Pregnancy
  • Report of a physical illness which is deemed active, unstable, degenerative, and/or progressive, such as congestive heart failure, dementia, or acute pain.
  • Bipolar disorder as defined by a manic or hypomanic episode or treatment within the past 10 years.
  • Severe depression.
  • Endorse risk of suicide.
  • Endorse alcohol or drug abuse within the past year.
  • Presence of another untreated sleep disorder (e.g., sleep apnea, periodic leg movements).
  • Have irregular sleep schedules, with usual bedtimes earlier than 8:00pm or later than 2:00am or arising times earlier than 4:00am or later than 10:00am.
  • Current psychological treatment for insomnia.
  • Initiating psychological treatment within past 3 months.
  • Unstable medication regimen (change to schedule or dosage within past 3 months) for a medication regimen thought to impact sleep.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438697

Locations
United States, Virginia
University Of Virginia Health System, Department of Psychiatry and Neurobehavioral Sciences, Division of Behavioral Health and Technology Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Rachael Maynard, MPH    434-982-5947    rlm2bc@virginia.edu   
Principal Investigator: Karen Ingersoll, PhD         
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Karen Ingersoll, PhD University Of Virginia Behavioral Health & Technology
Study Director: Lee M Ritterband, PhD University of Virginia Behavioral Health & Technology
  More Information

Additional Information:
Publications:
Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT01438697     History of Changes
Other Study ID Numbers: 15704, 1R01MH086758-01A1
Study First Received: September 20, 2011
Last Updated: December 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
sleep
insomnia
internet
CBT

ClinicalTrials.gov processed this record on September 29, 2014